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1. Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency

Author

Mascolo, M.C., Cursaro, C., Scuteri, A., Ranieri, J., Monti, M., Bellentani, S., Gasbarrini, A., Pompili, M., Puoti, C., Bellis, L., Regazzetti, A., Maffezzini, E., Pietrangelo, A., Abbati, G., Raimondo, G., Scribano, L., Martines, D., Baroni, G. Svegliati, Faraci, G., Schianchi, S., Fornaciari, G., Fabris, P., Madonia, S., Civitavecchia, G., Pirisi, M., Smirne, C., Borghi, A., Sardini, C., Andreoletti, M., Morisco, F., Caporaso, N., Fargion, S., Fatta, E., Masutti, F., Bonaventura, M.E., Autolitano, A., Russello, M., Bellia, A., Toniutto, P., Bitetto, D., Mecenate, F., Pasulo, L., Lucà, M.G., Picardi, A., Vespasiani, U., Grattagliano, I., Palasciano, G., Romagno, D., Crespi, C., Gianstefani, A., Gobbo, G., Monti, V., Giannelli, G., Napoli, N., Nosotti, Raspanti, A., Cuccorese, Colombo, A.E., Floridia, Plattella, M.S., Cassano, P., Gentile, I., Blanc, P.L., Messina, V., Bonfante, S., Bellissima, P., Toti, M., Vecchiet, J., Falasca, K., Portelli, V., De Stefano, G., Pietromatera, G., Viganò, P., Re, T., Andreoni, M., Raineri, G., Massari, M., Grossi, P.A., Caputo, S., Cassola, G., Feasi, M., Foti, G., Kunkar, A., Corti, G., Baragli, F., Caterini, L., Migliorini, D., Chiodera, A., Calleri, G., Spezia, C., Baiguera, C., Puoti, M., Brancaccio, G., Gaeta, G.B., Vento, S., Di Biagio, A., Nicolini, L., Liberti, A., Iannece, M.D., Contini, C., Tacconi, D., Caremani, M., Almi, P., Chimenti, M., Cosco, Messeri, D., Esperti, F.C., Paffetti, A., Mastropietro, C., Moretti, A., Spagnolo, A.L., Lomonaco, L., Calì, A., Mandelli, G., Spinzi, G.C., Framarin, L., Berrutti, M., Boccia, S., Simone, L., Pazzi, P., Fornari, F., Comparato, G., Casetti, T., Foschi, F.G., Bertin, T., Salvagnini, M., Samori, A., Ferretti, E., Casiraghi, M.A., Marin, R., Ciancio, A., Campo, N., Testa, R., Rocco, A., Federico, A., Loguercio, C., Rizzo, S., Giannini, E.G., Corbo, M., Riegler, G., Esposito, P., Ricci, G.L., Rosina, Floriano, Tosti, Maria Elena, Borghesio, Elisabetta, Masocco, Maria, Mele, Alfonso, Coppola, Carmine, Milella, Michele, Borgia, Guglielmo, Andreone, Pietro, Koch, Maurizio, Zignego, Anna Linda, Romano, Mario, Carrara, Maurizio, Almasio, Piero Luigi, Azzola, Emilio, Nardone, Gerardo, Benedetti, Antonio, Carosi, Giampiero, Mazzotta, Francesco, Sagnelli, Evangelista, and Rizzetto, Mario

Published
2014
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2. Impact of new DAA therapy on real clinical practice: a multicenter region-wide cohort study

Author

Lanini, Simone, Scognamiglio, Paola, Mecozzi, Alessandra, Lombardozzi, Lorella, Vullo, Vincenzo, Angelico, Mario, Gasbarrini, Antonio, Taliani, Gloria, Attili, Adolfo Francesco, Perno, Carlo Federico, De Santis, Adriano, Puro, Vincenzo, Cerqua, Fabio, D'Offizi, Gianpiero, Pellicelli, Adriano, Armignacco, Orlando, Mennini, Francesco Saverio, Siciliano, Massimo, Girardi, Enrico, Panella, Vincenzo, Ippolito, Giuseppe, Sarrecchia, C., Di Paolo, M. D., Francioso, S., Brega, A., Lenci, I., Sarmati, L., Pompili, Maurizio, Grieco, Antonio, Tamburrini, Enrica, Apaccini, R., Miele, Luca, D'Ettorre, G., Mezzaroma, I., Furlan, C., Accapezzato, D., Paoletti, F., Merili, M., Corradini, S., Sereno, S., Fimiani, C., Mastropietro, C., Labbadia, G., Gentile, Giuseppe, Pasquazzi, C., Marignani, M., Guarisco, R., Puoti, C., Spilabotti, L., Montalbano, M., Boumis, E., Visco-Comandini, U., Zaccarelli, M., Ammassari, A., Lionetti, R., Murachelli, S., Loiacono, L., Antinori, Armando, Noto, P., Palmieri, F., Cicalini, S., Cerilli, S., Sampaolesi, A., Vincenzi, L., Bellagamba, R., Galati, V., Abdeddaim, A., Iacomi, F., Iannicelli, G., Mastroianni, Chiara, Lichtner, M., Ridola, L., Coluzzi, T., Mercurio, V., Del Borgo, C., Fondacaro, L., Cerasari, G., Guarascio, P., D'Ambrosio, C., Starnini, G., Caterini, A., Villani, Emanuele Rocco, Sarracino, L., Casinelli, K., Moretti, A., Vespasiani, U., Galati, G., Cecere, R., Bonaventura, M., and Scudieri, M.

Subjects
Male, Cirrhosis, Investigational, chronic hepatitis c, clinical study, direct acting antiviral, hepatitis c virus, liver cirrhosis, liver damage, mixed effect model, multicenter cohort study, new therapy, treatment efficacy, Logistic regression, Chronic hepatitis C, Cohort Studies, 0302 clinical medicine, Clinical study, Direct acting antiviral, Hepatitis C virus, Liver cirrhosis, Liver damage, Mixed effect model, Multicenter cohort study, New therapy, Treatment efficacy, Adult, Aged, Aged, 80 and over, Antiviral Agents, Drug Therapy, Combination, Drugs, Investigational, Female, Follow-Up Studies, Hepatitis C, Chronic, Humans, Liver Cirrhosis, Middle Aged, Therapies, Investigational, 80 and over, 030212 general & internal medicine, Stage (cooking), Chronic, Confounding, Drugs, Hepatitis C, Infectious Diseases, Cohort, Combination, Settore SECS-P/03 - Scienza delle Finanze, 030211 gastroenterology & hepatology, Cohort study, Research Article, medicine.medical_specialty, Side effect, Hepatitis C virus, Chronic hepatitis C, Liver cirrhosis, Direct acting antiviral, Multicenter cohort study, Mixed effect model, Liver damage, Treatment efficacy, Clinical study, New therapy, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, lcsh:RC109-216, business.industry, Settore MED/09 - MEDICINA INTERNA, medicine.disease, Clinical trial, Therapies, business
Abstract

Background Management of chronic hepatitis C (CHC) has significantly accelerated in the last few years. Currently, second generation direct acting antivirals (DAAs) promise clearance of infection in most of patients. Here we present the results of the first analysis carried out on data of Lazio clinical network for DAAs. Methods The study was designed as a multicenter cohort: a) to assess the evolution of treatment during the first 24 months of the activity of the Clinical Network; b) to report overall efficacy of treatments; c) to analyze potential factors associated with lack of virological response at 12 weeks after therapy (SVR12); d) to evaluate the variation of ALT at baseline and 12 weeks after therapy in those who achieved SVR12 in comparison to those who did not. Analyses of efficacy were carried out with multilevel mixed effect logistic regression model. ALT temporal variation was assessed by mixed effect model mixed models with random intercept at patient’s level and random slope at the level of the time; i.e. either before or after therapy. Results Between 30 December 2014 and 31 December 2016 5279 patients started a DAA treatment; of those, 5127 (in 14 clinical centers) had completed the 12-week follow-up. Overall proportion of SVR12 was 93.41% (N = 4780) with no heterogeneity between the 14 clinical centers. Interruption as the consequence of severe side effect was very low (only 23 patients). Unadjusted analysis indicates that proportion of SVR12 significantly changes according to patient’s baseline characteristics, however after adjusting for potential confounders only adherence to current guidelines, stage of liver diseases, gender, transplant and HIV status were independently associated with the response to therapy. Analysis of ALT temporal variation showed that ALT level normalized in most, but not, all patients who achieved SVR12. Conclusion Our study confirmed the extraordinary efficacy of DAAs outside clinical trials. The advantage of DAAs was particularly significant for those patients who were previously considered as difficult-to-treat and did not have treatment options before DAAs era. Intervention based on network of select centers and prioritization of patients according to diseases severity was successful. Further studies are needed to establish whether clearance of HCV after DAAs therapy can arrest or even revert liver fibrosis in non-cirrhotic patients and/or improve life quality and expectancy in those who achieve SVR12 with cirrhosis.

Published
2018
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3. Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: A multicentre independent study supported by the Italian Drug Agency

Author

Rosina, Floriano, Tosti, Maria Elena, Borghesio, Elisabetta, Masocco, Maria, Mele, Alfonso, Coppola, Carmine, Milella, Michele, Borgia, Guglielmo, Andreone, Pietro, Koch, Maurizio, Zignego, Anna Linda, Romano, Mario, Carrara, Maurizio, Almasio, Piero Luigi, Azzola, Emilio, Nardone, Gerardo, Benedetti, Antonio, Carosi, Giampiero, Mazzotta, Francesco, Sagnelli, Evangelista, Rizzetto, Mario, Mascolo, M. C., Cursaro, C., Scuteri, A., Crespi, C., Gianstefani, A., Ranieri, J., Monti, M., Corti, G., Blanc, P. L., Baragli, F., Bellentani, S., Gasbarrini, A., Pompili, M., Mecenate, F., Picardi, A., Vespasiani, U., Nosotti, Null, Null, A. Picardi, Ricci, G. L., Paffetti, A., Mastropietro, C., Moretti, A., Spagnolo, A. L., Puoti, C., Bellis, L., Regazzetti, A., Maffezzini, E., Pietrangelo, A., Abbati, G., Borghi, A., Sardini, C., Raimondo, G., Scribano, L., Martines, D., Svegliati Baroni, G., Faraci, G., Schi anchi, S., Fornaciari, G., Massari, M., Fabris, P., Bertin, T., Salvagnini, M., Madonia, S., Calì, A., Civitavecchia, G., Pirisi, M., Smirne, C., Andreoletti, M., Morisco, F., Caporaso, N., Gentile, I., Brancaccio, G., Gaeta, G. B., Liberti, A., Iannece, M. D., Rocco, A., Federico, A., Loguercio, C., Riegler, G., Esposito, P., Fargion, S., Fatta, E., Masutti, F., Bonaventura, M. E., Autolitano, A., Russello, M., Bellia, A., Toniutto, P., Bitetto, D., Pasulo, L., Lucà, M. G., Grattagliano, I., Palasciano, G., Romagno, D., Giannelli, G., Napoli, N., Plattella, M. S., Cassano, P., Gobbo, G., Monti, V., Raspanti, A., Cuccorese, Null, Colombo, A. E., Mandelli, G., Spinzi, G. C., Floridia, Null, Messina, V., Bonfante, S., Bellissima, P., Toti, M., Vecchiet, J., Falasca, K., Portelli, V., Stefano, G. De, Pietromatera, G., Viganò, P., Re, T., Andreoni, M., Null, G. Raineri, Grossi, P. A., Caputo, S., Cassola, G., Feasi, M., Biagio, A. Di, Nicolini, LAURA AMBRA, Giannini, EDOARDO GIOVANNI, Corbo, M., Foti, G., Kunkar, A., Caterini, L., Migliorini, D., Chiodera, A., Calleri, G., Spezia, C., Framarin, L., Null, M. Berrutti, Ciancio, A., Baiguera, C., Puoti, M., Vento, S., Contini, C., Boccia, S., Casiraghi, M. A., Simone, L., Tacconi, D., Caremani, M., Almi, P., Chimenti, M., Cosco, Null, Messeri, D., Esperti, F. C., Lomonaco, L., Pazzi, P., Fornari, F., Comparato, G., Casetti, T., Foschi, F. G., Samori, A., Ferretti, E., Marin, R., Campo, N., Testa, R., Rizzo, S., Rosina, F, Tosti, ME, Borghesio, E, Masocco, M, Mele, A, Coppola, C, Milella, M, Borgia, G, Andreone, P, Koch, M, Zignego, AL, Romano, M, Carrara, M, Almasio, PL, Azzola, E, Nardone, G, Benedetti, A, Carosi, G, Mazzotta, F, Sagnelli, E, Rizzetto, M, Rosina, F., Tosti, M. E., Borghesio, E., Masocco, M., Mele, A., Coppola, C., Milella, M., Borgia, Guglielmo, Andreone, P., Koch, M., Zignego, A. L., Romano, M., Carrara, M., Almasio, P. L., Azzola, E., Nardone, GERARDO ANTONIO PIO, Benedetti, A., Carosi, G., Mazzotta, F., Sagnelli, E., Rizzetto, M., Aifa, Aisf, Simit, Aigo, Sige, Gentile, Ivan, Morisco, Filomena, Et, Al, Floriano Rosina, Maria Elena Tosti, Elisabetta Borghesio, Maria Masocco, Alfonso Mele, Carmine Coppola, Michele Milella, Guglielmo Borgia, Pietro Andreone, Maurizio Koch, Anna Linda Zignego, Mario Romano, Maurizio Carrara, Piero Luigi Almasio, Emilio Azzola, Gerardo Nardone, Antonio Benedetti, Giampiero Carosi, Francesco Mazzotta, Evangelista Sagnelli, and Mario Rizzetto

Subjects
Registrie, Male, Cirrhosis, medicine.disease_cause, Polyethylene Glycol, Gastroenterology, Polyethylene Glycols, chemistry.chemical_compound, Hepatitis Viruses, Hepatitis Viruse, Prospective Studies, Viral, Registries, Chronic, Prospective cohort study, Drug Carrier, Drug Carriers, Settore MED/12 - Gastroenterologia, Medicine (all), Recombinant Protein, Middle Aged, Hepatitis C, Recombinant Proteins, Treatment Outcome, Italy, Combination, RNA, Viral, Population study, Drug Therapy, Combination, Female, Human, medicine.medical_specialty, Genotype, Hepatitis C virus, Alpha interferon, Ribavirin, Sustained virological response (SVR), Treatment, Antiviral Agents, Follow-Up Studie, Hepatology, Drug Therapy, Internal medicine, medicine, Humans, Antiviral Agent, business.industry, Interferon-alpha, HCV therapy, Hepatitis C, Chronic, medicine.disease, Clinical trial, Prospective Studie, chemistry, Immunology, RNA, Follow-Up Studies, business
Abstract

a b s t r a c t Background: Data on the efficacy of Peg-interferon/ribavirin therapy for chronic hepatitis C are mostly derived from treatment of selected patients enrolled in clinical trials. This study aimed to assess the effectiveness of Peg-interferon/ribavirin therapy in “real world” chronic hepatitis C patients in Italy. Methods: Independent observational multicentre study including consecutive patients receiving Peginterferon/ribavirin in the 18 months before (retrospective phase) and after (prospective phase) the start of the study. Results: 4176 patients were eligible. The final study population consisted of 2051 patients in the retrospective and 2073 in the prospective phase. Sustained virological response was achieved by 1036 patients (50.5%) during the retrospective phase: 325 were genotypes 1/4 (34.1%) and 684 were genotypes 2/3 (67.2%) and by 800 patients (38.6%) during the prospective phase: 300 were genotypes 1/4 (28.4%) and 473 were genotypes 2/3 (51.5%). During multivariate analysis genotypes 2/3 were significantly associated with higher sustained virological response rates; cirrhosis and -glutamil-transpeptidase >2 times the normal limit were associated with poorer response. Conclusions: The response to Peg-interferon/ribavirin therapy in “real world” clinical practice is distinctly lower than in registration trials. The difference in response rates was more pronounced among easy-totreat than among difficult-to-treat hepatitis C virus genotypes.

Published
2014

4. The efficacy of radiofrequency volumetric tissue reduction of hypertrophied inferior turbinate in simple snoring.

Author

CASALE, M., BOTTARO, V., SABATINO, L., FRARI, V., BRESSI, F., VESPASIANI, U., BAPTISTA, R., and SALVINELLI, F.

Abstract

BACKGROUND: Simple snoring represents a social problem, not only because it could affect the patient's married life, but it often goes along with sleep-disordered breathing. Chronic nasal obstruction has many sequel including snoring and the inferior turbinate hypertrophy (ITH) is its most common cause. The aim of the study is to evaluate the efficacy of video-assisted endoscopic radiofrequency volumetric tissue reduction (RFVTR) to reduce snoring in patients affected by chronic nasal obstruction due to ITH. PATIENTS AND METHODS: This prospective study was conducted over 48 habitual snoring with persistent nasal obstruction due to bilateral ITH refractory to medical management received one time RFVTR of both it. Nasal symptoms were assessed both subjectively, by Visual Analog Scale (VAS) and NOSE Scale, and objectively by videorhinohygrometer. Snoring was measured by Snoring severity rated by the bed partner, in a longitudinal fashion, using VAS. All patients were evaluated pre-operatively, and after 45th day (range 35-50 days) post-operatively. RESULTS: Thirty-two subjects completed study. All patients had significant symptomatic improvement in nasal breathing (5.53 ± 2.88 vs 1.87 ± 1.75; p < 0.05), confirmed by videorhinohygrometer values (p < 0.05). We had a significantly improvement of snoring in all patients (5.62 ± 2.80 vs 1.86 ± 1.43, p < 0.001) with a mean snoring Visual Analog Scale improvement of 77.4%. CONCLUSIONS: Based on this study and literature review, it seems that RFVTR represents a safe, minimal invasive, easy performed, and time and cost effective surgery, which may decrease symptoms of snoring in patients with ITH, at least, in short-term follow-up. [ABSTRACT FROM AUTHOR]

Published
2014

5. The role of S-adenosylmethionine in preventing oxaliplatin-induced liver toxicity: a retrospective analysis in metastatic colorectal cancer patients treated with bevacizumab plus oxaliplatin-based regimen.

Author

Vincenzi B, Daniele S, Frezza AM, Berti P, Vespasiani U, Picardi A, Tonini G, Vincenzi, Bruno, Daniele, Santini, Frezza, Anna Maria, Berti, Pierpaolo, Vespasiani, Umberto, Picardi, Antonio, and Tonini, Giuseppe

Abstract

Background: Hepatotoxicity represents a frequent chemotherapy-related side effect, often associated with course delays, discontinuations, and dose reductions. S-adenosylmethionine (AdoMet) administration is effective in the treatment of a variety of liver injuries, but it has never been evaluated in the prevention of chemotherapy-induced damage.Patients and Methods: Seventy-eight patients affected by metastatic colorectal cancer were enrolled. Forty-two patients were treated with bevacizumab and XELOX without administering AdoMet, 32 were treated with the same regimen plus supplementation with AdoMet. Liver enzymes levels were assessed before starting the treatment, and then every therapy cycle, liver toxicity, chemotherapy course delays, discontinuations, and dose reductions due to liver toxicity were recorded.Results: Aspartate aminotransferase (P = 0.02), alanine transaminase (P < 0.001), lactate dehydrogenase (P = 0.008), total bilirubin (P = 0.03), and gamma-glutamyltransferase (P < 0.001) were found to be significantly lower in patients treated with AdoMet than in those who were not. Patients supplemented with AdoMet experimented a lower grade of liver toxicity (P = 0.009) and had a reduced need of course delay (P = 0.042) and dose reduction (P = 0.051).Conclusions: AdoMet supplementation in patients affected by metastatic colorectal cancer treated with oxaliplatin-based regimen seems to be effective in the prevention of chemotherapy-induced liver injury. [ABSTRACT FROM AUTHOR]

Published
2012
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6. The efficacy of radiofrequency volumetric tissue reduction of hypertrophied inferior turbinate in simple snoring

Author

Casale, M., Bottaro, V., Lorenzo Sabatino, Frari, V., Bressi, F., Vespasiani, U., Baptista, P., and Salvinelli, F.

Subjects
Adult, Male, Young Adult, Snoring, Humans, Endoscopy, Female, Hypertrophy, Prospective Studies, Middle Aged, Nasal Obstruction, Nose, Turbinates
Abstract

Simple snoring represents a social problem, not only because it could affect the patient's married life, but it often goes along with sleep-disordered breathing. Chronic nasal obstruction has many sequel including snoring and the inferior turbinate hypertrophy (ITH) is its most common cause. The aim of the study is to evaluate the efficacy of video-assisted endoscopic radiofrequency volumetric tissue reduction (RFVTR) to reduce snoring in patients affected by chronic nasal obstruction due to ITH.This prospective study was conducted over 48 habitual snoring with persistent nasal obstruction due to bilateral ITH refractory to medical management received one time RFVTR of both it. Nasal symptoms were assessed both subjectively, by Visual Analog Scale (VAS) and NOSE Scale, and objectively by videorhinohygrometer. Snoring was measured by Snoring severity rated by the bed partner, in a longitudinal fashion, using VAS. All patients were evaluated pre-operatively, and after 45th day (range 35-50 days) post-operatively.Thirty-two subjects completed study. All patients had significant symptomatic improvement in nasal breathing (5.53 ± 2.88 vs 1.87 ± 1.75; p0.05), confirmed by videorhinohygrometer values (p0.05). We had a significantly improvement of snoring in all patients (5.62 ± 2.80 vs 1.86 ± 1.43, p0.001) with a mean snoring Visual Analog Scale improvement of 77.4%.Based on this study and literature review, it seems that RFVTR represents a safe, minimal invasive, easy performed, and time and cost effective surgery, which may decrease symptoms of snoring in patients with ITH, at least, in short-term follow-up.

7. Clinical usefulness of HCV sequencing on clinical samples with different HCV-RNA levels

Author

Ceccherini-Silberstein, F., Di Maio, V. C., Cento, V., Di Paolo, D., Aragri, M., Leonardis, F., Tontodonati, M., Valeria Micheli, Antonucci, F. P., Campoli, R., Mancon, A., Bertoli, A., Lenci, I., Cucchiarelli, S., Manunta, A., Di Biagio, A., Sarrecchia, C., Nicolini, L. A., Marenco, S., Ciotti, M., Nosotti, L., Gianelli, V., Merli, M., Siciliano, M., Landonio, S., Maria, A., Pellicelli, A., Vecchiet, J., Magni, C., Babudieri, S., Mura, M. S., Taliani, G., Lichtner, M., Maida, I., Vespasiani, U., Romano, M., Morisco, F., Gasbarrini, A., Mastroianni, C., Puoti, M., Mangia, A., Bruno, S., Tisone, G., Caporaso, N., Picciotto, A., Andreoni, M., Parruti, G., Rizzardini, G., Angelico, M., and Perno, C. F.

8. Exploring the efficacy and safety of single-agent sorafenib in a cohort of Italian patients with hepatocellular carcinoma

Author

Daniele Santini, Giuseppe Tonini, Antonio Picardi, Michele Caraglia, Raffaele Addeo, Umberto Vespasiani, Liliana Montella, Bruno Vincenzi, Alice Calvieri, Marianna Silletta, Salvatore Del Prete, Santini, D, Addeo, R, Vincenzi, B, Calvieri, A, Montella, L, Silletta, M, Caraglia, Michele, Vespasiani, U, Picardi, A, Del Prete, S, and Tonini, G.

Subjects
Sorafenib, Male, Niacinamide, medicine.medical_specialty, hepatocellular carcinoma, retrospective, sorafenib, Carcinoma, Hepatocellular, Cohort Studies, Internal medicine, medicine, Overall survival, Humans, Pharmacology (medical), Single agent, Adverse effect, Aged, Retrospective Studies, Aged, 80 and over, Adult patients, business.industry, Phenylurea Compounds, Liver Neoplasms, Retrospective cohort study, Middle Aged, medicine.disease, digestive system diseases, Surgery, Treatment Outcome, Oncology, Italy, Hepatocellular carcinoma, Cohort, Disease Progression, Female, business, medicine.drug
Abstract

This study investigates the effectiveness and safety of sorafenib in a heterogeneous cohort of Child-Pugh A, B and C patients with advanced hepatocellular carcinoma in a clinical-practice scenario. Adult patients with hepatocellular carcinoma and treated with sorafenib 800 mg/day were eligible for this multicentric retrospective observational study. Safety analyses were performed and the effectiveness of sorafenib was assessed in terms of time to progression (TTP) and overall survival (OS). In total, 93 patients were enrolled: 14 were Child-Pugh A, 70 were Child-Pugh B and nine were Child-Pugh C. No differences in the frequency of grade 3 adverse events among different Child-Pugh classes were reported. In the overall cohort, median OS was 12 months (95% CI: 11.7-12.8 months) and TTP was 3 months (95% CI: 2.5-3.4 months). The Child-Pugh score had a statistically significant effect on TTP: 6.6 months in Child-Pugh A, 2.8 months in Child-Pugh B and 2.0 months in Child-Pugh C patients (p = 0.012). To our knowledge, this study includes the largest cohort of Caucasian Child-Pugh B and C patients ever treated with sorafenib. Although the retrospective design of this study does not allow reaching any definite conclusion, the results could lend some preliminary support to the safety and the effectiveness of sorafenib monotherapy in patients with Child-Pugh B and Child-Pugh C liver function.

9. Severe hypophosphatemic osteomalacia secondary to fanconi syndrome due to adefovir: a case report.

Author

Palermo A, Strollo R, Papalia R, D'Onofrio L, Maddaloni E, Briganti SI, Napoli N, Vespasiani U, Costantino S, Pozzilli P, Denaro V, and Manfrini S

Abstract

Objective: Generalized proximal, type 2, renal tubular acidosis, also known as Fanconi syndrome, is a generalized dysfunction of the proximal renal tubule characterized by impaired reabsorption and increased urinary loss of phosphate and other solutes, such as uric acid, glucose, amino acids, and bicarbonate. Chronic hypophosphatemia is the second most common cause of osteomalacia after vitamin D deficiency in adult patients and can have a heterogeneous presentation, ranging from mild symptoms such as muscle weakness and skeletal pain to more severe presentation, such as disabling myopathy, severe bone and joint pain, difficulty walking, and even bone fractures., Methods: This report describes a case of severe hypophosphatemic osteomalacia with multiple fragility fractures induced by adefovir, which was worsened and confounded by a previous treatment with zoledronic acid and required prolonged intravenous potassium phosphate administration., Results: We highlight the limited diagnostic value of dual X-ray absorptiometry and bone scintigraphy in this challenging diagnosis. Bone metabolism should always be assessed in patients treated with adefovir for early detection of osteomalacia due to Fanconi syndrome., Conclusion: Although rare, this condition may be life-threatening and mimic other bone metabolic disorders that are treated with drugs that may further impair phosphate balance.

Published
2014
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10. Exploring the efficacy and safety of single-agent sorafenib in a cohort of Italian patients with hepatocellular carcinoma.

Author

Santini D, Addeo R, Vincenzi B, Calvieri A, Montella L, Silletta M, Caraglia M, Vespasiani U, Picardi A, Del Prete S, and Tonini G

Subjects
Aged, Aged, 80 and over, Carcinoma, Hepatocellular pathology, Cohort Studies, Disease Progression, Female, Humans, Italy, Liver Neoplasms pathology, Male, Middle Aged, Niacinamide adverse effects, Niacinamide therapeutic use, Retrospective Studies, Sorafenib, Treatment Outcome, Carcinoma, Hepatocellular drug therapy, Liver Neoplasms drug therapy, Niacinamide analogs & derivatives, Phenylurea Compounds adverse effects, Phenylurea Compounds therapeutic use
Abstract

This study investigates the effectiveness and safety of sorafenib in a heterogeneous cohort of Child-Pugh A, B and C patients with advanced hepatocellular carcinoma in a clinical-practice scenario. Adult patients with hepatocellular carcinoma and treated with sorafenib 800 mg/day were eligible for this multicentric retrospective observational study. Safety analyses were performed and the effectiveness of sorafenib was assessed in terms of time to progression (TTP) and overall survival (OS). In total, 93 patients were enrolled: 14 were Child-Pugh A, 70 were Child-Pugh B and nine were Child-Pugh C. No differences in the frequency of grade 3 adverse events among different Child-Pugh classes were reported. In the overall cohort, median OS was 12 months (95% CI: 11.7-12.8 months) and TTP was 3 months (95% CI: 2.5-3.4 months). The Child-Pugh score had a statistically significant effect on TTP: 6.6 months in Child-Pugh A, 2.8 months in Child-Pugh B and 2.0 months in Child-Pugh C patients (p = 0.012). To our knowledge, this study includes the largest cohort of Caucasian Child-Pugh B and C patients ever treated with sorafenib. Although the retrospective design of this study does not allow reaching any definite conclusion, the results could lend some preliminary support to the safety and the effectiveness of sorafenib monotherapy in patients with Child-Pugh B and Child-Pugh C liver function.

Published
2012
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11. The role of S-adenosyl methionine in preventing FOLFOX-induced liver toxicity: a retrospective analysis in patients affected by resected colorectal cancer treated with adjuvant FOLFOX regimen.

Author

Vincenzi B, Santini D, Frezza AM, Berti P, Vespasiani U, Picardi A, and Tonini G

Subjects
Adult, Aged, Alanine Transaminase metabolism, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Aspartate Aminotransferases metabolism, Bilirubin metabolism, Chemical and Drug Induced Liver Injury enzymology, Chemotherapy, Adjuvant, Female, Fluorouracil administration & dosage, Fluorouracil adverse effects, Humans, Leucovorin administration & dosage, Leucovorin adverse effects, Liver drug effects, Liver enzymology, Male, Middle Aged, Organoplatinum Compounds administration & dosage, Organoplatinum Compounds adverse effects, Retrospective Studies, gamma-Glutamyltransferase metabolism, Antineoplastic Combined Chemotherapy Protocols adverse effects, Chemical and Drug Induced Liver Injury etiology, Chemical and Drug Induced Liver Injury prevention & control, Colorectal Neoplasms drug therapy, S-Adenosylmethionine therapeutic use
Abstract

Background: Hepatic toxicity is often related to chemotherapy agent administration, and it represents one of the principal causes of dose reduction and chemotherapy delays or discontinuation. S-Adenosyl methionine (AdoMet) supplementation is effective in the treatment of a variety of liver injuries, but it has never been evaluated in the prevention of chemotherapy-induced liver damage., Patients and Methods: A total of 105 patients affected by resected colorectal cancer (CRC) were enrolled. Forty-five were treated with FOLFOX IV adjuvant regimen without administering AdoMet, 60 were treated with the same regimen plus supplementation with AdoMet. Liver enzyme levels were assessed before starting the treatment and every therapy cycle. Liver toxicity, chemotherapy course delays, discontinuations and dose reductions due to liver toxicity were recorded., Results: Aspartate aminotransferase (AST) (p < 0.001), alanine transaminase (ALT) (p = 0.003), bilirubin (p = 0.04) and gamma-glutamyltransferase (γ-GT) (p = 0.002) median level at the end of adjuvant therapy were significantly lower in patients treated with Adome. Patients supplemented with AdoMet experimented a lower grade of liver toxicity (p = 0.002) and had a reduced need of course delay (p < 0.0001) and dose reduction (p = 0.031)., Conclusions: The results of our study demonstrate a protective effect of AdoMet supplementation in patients affected by resected CRC treated with FOLFOX IV adjuvant regimen.

Published
2011
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